MANAGEMENT OF ADVERSE EVENTS IN PATIENTS WITH RELAPSED AND REFRACTORY MULTIPLE MYELOMA TREATED WITH POMALIDOMIDE PLUS LOW-DOSE DEXAMETHASONE: A POOLED SAFETY ANALYSIS OF 3 CLINICAL TRIALS
(Abstract release date: 05/19/16)
EHA Library. Moreau P. 06/09/16; 132833; E1284
Prof. Philippe Moreau
Contributions
Contributions
Abstract
Abstract: E1284
Type: Eposter Presentation
Background
Patients with relapsed and refractory multiple myeloma (RRMM) who are heavily pretreated often have advanced disease and comorbidities, increasing their susceptibility to adverse events (AEs). The management of AEs is important to ensure that patients remain on the therapy for as long as needed to receive a clinical benefit.
Aims
To further characterize the safety profile of pomalidomide (POM) + low-dose dexamethasone (LoDEX) and management of AEs using pooled safety data from 3 clinical trials of POM + LoDEX (Richardson et al, Blood, 2014; San Miguel et al, Lancet Oncol, 2013; Dimopoulos et al, ASH 2015).
Methods
The 3 trials enrolled patients who provided informed consent and had ≥ 2 prior therapies, including lenalidomide and bortezomib, and had progressed on or within 60 days of their last therapy. Patients received POM 4 mg/day on days 1-21 of each 28-day cycle and LoDEX 40 mg (20 mg for those > 75 years of age) weekly until disease progression or unacceptable toxicity. Thromboprophylaxis was required. Grouped AE terms were used for analysis.
Results
A total of 1088 patients from the 3 trials were included in the safety population; median age was 66 years (range, 34-88 years). Most patients were male (57%), had an Eastern Cooperative Oncology Group performance status of ≤ 1 (88%), were refractory to both lenalidomide and bortezomib (77%), and had prior stem cell transplant (68%). The most common grade 3/4 AEs were neutropenia (56%), infections (34%), anemia (32%), and thrombocytopenia (26%). The median time to onset was 20 days (range, 1-591 days) in the 693 patients with neutropenia, 15 days (range, 1-498 days) in the 393 patients with thrombocytopenia, and 41.5 days (range, 1-493 days) in the 748 patients with infections. AEs were managed by dose modifications and/or supportive care, including anti-infectives (88%), red blood cell transfusion (45%), granulocyte colony-stimulating factor (17%), and platelet transfusion (14%). The rate of grade 3/4 venous thromboembolic events was low (2%). Peripheral neuropathy (PN) of any grade occurred in 17% of patients; 1% experienced grade 3/4 PN. The median average POM dose was 4 mg (range, 1.6-4.2 mg). AEs leading to POM dose interruptions occurred in 66% of patients. AEs leading to dose reductions occurred in 24% of patients; the most common were neutropenia (8%), thrombocytopenia (5%), and infections (4%). AEs leading to discontinuation of POM were infrequent (7%).
Conclusion
In this large pooled safety analysis, POM + LoDEX showed an acceptable safety profile in patients with RRMM. AEs were manageable, and discontinuations due to AEs were uncommon.
Session topic: E-poster
Type: Eposter Presentation
Background
Patients with relapsed and refractory multiple myeloma (RRMM) who are heavily pretreated often have advanced disease and comorbidities, increasing their susceptibility to adverse events (AEs). The management of AEs is important to ensure that patients remain on the therapy for as long as needed to receive a clinical benefit.
Aims
To further characterize the safety profile of pomalidomide (POM) + low-dose dexamethasone (LoDEX) and management of AEs using pooled safety data from 3 clinical trials of POM + LoDEX (Richardson et al, Blood, 2014; San Miguel et al, Lancet Oncol, 2013; Dimopoulos et al, ASH 2015).
Methods
The 3 trials enrolled patients who provided informed consent and had ≥ 2 prior therapies, including lenalidomide and bortezomib, and had progressed on or within 60 days of their last therapy. Patients received POM 4 mg/day on days 1-21 of each 28-day cycle and LoDEX 40 mg (20 mg for those > 75 years of age) weekly until disease progression or unacceptable toxicity. Thromboprophylaxis was required. Grouped AE terms were used for analysis.
Results
A total of 1088 patients from the 3 trials were included in the safety population; median age was 66 years (range, 34-88 years). Most patients were male (57%), had an Eastern Cooperative Oncology Group performance status of ≤ 1 (88%), were refractory to both lenalidomide and bortezomib (77%), and had prior stem cell transplant (68%). The most common grade 3/4 AEs were neutropenia (56%), infections (34%), anemia (32%), and thrombocytopenia (26%). The median time to onset was 20 days (range, 1-591 days) in the 693 patients with neutropenia, 15 days (range, 1-498 days) in the 393 patients with thrombocytopenia, and 41.5 days (range, 1-493 days) in the 748 patients with infections. AEs were managed by dose modifications and/or supportive care, including anti-infectives (88%), red blood cell transfusion (45%), granulocyte colony-stimulating factor (17%), and platelet transfusion (14%). The rate of grade 3/4 venous thromboembolic events was low (2%). Peripheral neuropathy (PN) of any grade occurred in 17% of patients; 1% experienced grade 3/4 PN. The median average POM dose was 4 mg (range, 1.6-4.2 mg). AEs leading to POM dose interruptions occurred in 66% of patients. AEs leading to dose reductions occurred in 24% of patients; the most common were neutropenia (8%), thrombocytopenia (5%), and infections (4%). AEs leading to discontinuation of POM were infrequent (7%).
Conclusion
In this large pooled safety analysis, POM + LoDEX showed an acceptable safety profile in patients with RRMM. AEs were manageable, and discontinuations due to AEs were uncommon.
Session topic: E-poster
Abstract: E1284
Type: Eposter Presentation
Background
Patients with relapsed and refractory multiple myeloma (RRMM) who are heavily pretreated often have advanced disease and comorbidities, increasing their susceptibility to adverse events (AEs). The management of AEs is important to ensure that patients remain on the therapy for as long as needed to receive a clinical benefit.
Aims
To further characterize the safety profile of pomalidomide (POM) + low-dose dexamethasone (LoDEX) and management of AEs using pooled safety data from 3 clinical trials of POM + LoDEX (Richardson et al, Blood, 2014; San Miguel et al, Lancet Oncol, 2013; Dimopoulos et al, ASH 2015).
Methods
The 3 trials enrolled patients who provided informed consent and had ≥ 2 prior therapies, including lenalidomide and bortezomib, and had progressed on or within 60 days of their last therapy. Patients received POM 4 mg/day on days 1-21 of each 28-day cycle and LoDEX 40 mg (20 mg for those > 75 years of age) weekly until disease progression or unacceptable toxicity. Thromboprophylaxis was required. Grouped AE terms were used for analysis.
Results
A total of 1088 patients from the 3 trials were included in the safety population; median age was 66 years (range, 34-88 years). Most patients were male (57%), had an Eastern Cooperative Oncology Group performance status of ≤ 1 (88%), were refractory to both lenalidomide and bortezomib (77%), and had prior stem cell transplant (68%). The most common grade 3/4 AEs were neutropenia (56%), infections (34%), anemia (32%), and thrombocytopenia (26%). The median time to onset was 20 days (range, 1-591 days) in the 693 patients with neutropenia, 15 days (range, 1-498 days) in the 393 patients with thrombocytopenia, and 41.5 days (range, 1-493 days) in the 748 patients with infections. AEs were managed by dose modifications and/or supportive care, including anti-infectives (88%), red blood cell transfusion (45%), granulocyte colony-stimulating factor (17%), and platelet transfusion (14%). The rate of grade 3/4 venous thromboembolic events was low (2%). Peripheral neuropathy (PN) of any grade occurred in 17% of patients; 1% experienced grade 3/4 PN. The median average POM dose was 4 mg (range, 1.6-4.2 mg). AEs leading to POM dose interruptions occurred in 66% of patients. AEs leading to dose reductions occurred in 24% of patients; the most common were neutropenia (8%), thrombocytopenia (5%), and infections (4%). AEs leading to discontinuation of POM were infrequent (7%).
Conclusion
In this large pooled safety analysis, POM + LoDEX showed an acceptable safety profile in patients with RRMM. AEs were manageable, and discontinuations due to AEs were uncommon.
Session topic: E-poster
Type: Eposter Presentation
Background
Patients with relapsed and refractory multiple myeloma (RRMM) who are heavily pretreated often have advanced disease and comorbidities, increasing their susceptibility to adverse events (AEs). The management of AEs is important to ensure that patients remain on the therapy for as long as needed to receive a clinical benefit.
Aims
To further characterize the safety profile of pomalidomide (POM) + low-dose dexamethasone (LoDEX) and management of AEs using pooled safety data from 3 clinical trials of POM + LoDEX (Richardson et al, Blood, 2014; San Miguel et al, Lancet Oncol, 2013; Dimopoulos et al, ASH 2015).
Methods
The 3 trials enrolled patients who provided informed consent and had ≥ 2 prior therapies, including lenalidomide and bortezomib, and had progressed on or within 60 days of their last therapy. Patients received POM 4 mg/day on days 1-21 of each 28-day cycle and LoDEX 40 mg (20 mg for those > 75 years of age) weekly until disease progression or unacceptable toxicity. Thromboprophylaxis was required. Grouped AE terms were used for analysis.
Results
A total of 1088 patients from the 3 trials were included in the safety population; median age was 66 years (range, 34-88 years). Most patients were male (57%), had an Eastern Cooperative Oncology Group performance status of ≤ 1 (88%), were refractory to both lenalidomide and bortezomib (77%), and had prior stem cell transplant (68%). The most common grade 3/4 AEs were neutropenia (56%), infections (34%), anemia (32%), and thrombocytopenia (26%). The median time to onset was 20 days (range, 1-591 days) in the 693 patients with neutropenia, 15 days (range, 1-498 days) in the 393 patients with thrombocytopenia, and 41.5 days (range, 1-493 days) in the 748 patients with infections. AEs were managed by dose modifications and/or supportive care, including anti-infectives (88%), red blood cell transfusion (45%), granulocyte colony-stimulating factor (17%), and platelet transfusion (14%). The rate of grade 3/4 venous thromboembolic events was low (2%). Peripheral neuropathy (PN) of any grade occurred in 17% of patients; 1% experienced grade 3/4 PN. The median average POM dose was 4 mg (range, 1.6-4.2 mg). AEs leading to POM dose interruptions occurred in 66% of patients. AEs leading to dose reductions occurred in 24% of patients; the most common were neutropenia (8%), thrombocytopenia (5%), and infections (4%). AEs leading to discontinuation of POM were infrequent (7%).
Conclusion
In this large pooled safety analysis, POM + LoDEX showed an acceptable safety profile in patients with RRMM. AEs were manageable, and discontinuations due to AEs were uncommon.
Session topic: E-poster
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